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Sep 24 2014 1:00PM - Sep 25 2014 5:00PM | NH Musica
van Leijenberghlaan 221
1082 GG Amsterdam
Biorelevant in-vitro performance testing of orally administered dosage forms has become an important tool for the assessment of drug product in vivo behaviour. Biorelevant dissolution/release testing is useful for the evaluation of formulation and food effects on plasma levels and intraluminal dosage form performance after administration of oral drug products. It has also been utilised to decrease the number of in-vivo studies required during the drug development process and to mitigate the risk related to in vivo bioequivalence studies.
This workshop will discuss data on the luminal environment, its simulation, biorelevant in vitro performance testing methodologies that can be applied during product development, as well as relevant in-silico modelling methodologies. Case studies from industry will describe the application of biorelevant testing methodologies for formulation design, selection and development vs. currently applied procedures in quality control testing. In addition, presentations from the FDA and National Competent Authorities will cover the use of biorelevant testing in the evaluation of a drug’s performance.
Gastrointestinal Physiology and in vitro Simulation
Biopharmaceutics Tools: A European academic-industry consortium
PBPK Modelling of Oral Drug Absorption
Looking at the Regulators
There will be a discussion and a chance for attendees to ask questions at the end of each session.
Scientists from industry, academia and regulatory agencies, including graduate students with a primary interest in development of orally administered drug products. The programme is designed to benefit scientists, who are already working in oral dosage formulation development
We have blocked a limited number of rooms at:Hotel NH MusicaVan Leijenberghlaan 2211082 GG AmsterdamThe Netherlands
Tel.: +31 20 541 41 41Email: email@example.com
To make a booking, go to:http://www.nh-hotels.com/events/en/event-detail/20681/_.html
At the rate of EUR 140.00 per room/night inclusive of VAT and breakfast, exclusive of city tax.
Registration QueriesDIA EMEA Contact CenterPhone: +41 61 225 51 51 Fax: +41 61 225 51 52 Monday - Friday 8:00 - 17:00 CETdiaeurope@diaeurope.org
Agenda and Event LogisticsMara Canova, Event PlannerPhone: +41 61 225 51 40Fax: +41 61 225 51 firstname.lastname@example.org
Head of External AffairsBayer Pharma AG, Germany
Professor of PharmaceuticsNational and Kapodistrian University of Athens, Greece
Director Analytical Sciences Research and DevelopmentEli Lilly&Co, United States
Director, DPAFDA, United States
Director, Non-Complex ActivesUS Pharmacopeia, United States
DirectorEuropean Directorate For the Quality of Medicines & Healthcare (EDQM), France
Managing DirectorPHAST GmbH, Germany
Pharmaceutical DirectorIrish Medicines Board, Ireland
Pharmaceutical ConsultantPharmaceutical Consultant, United States
Biorelevant In Vitro Tests